Study to Assess the Occurrence of HPA-1a Alloimmunization in Women With Higher Risk for Fetal and Neonatal Alloimmune Thrombocytopenia

Brief Title

Study to Assess the Occurrence of HPA-1a Alloimmunization in Women With Higher Risk for Fetal and Neonatal Alloimmune Thrombocytopenia

Official Title

A Prospective, Natural History Study to Assess the Occurrence of HPA-1a Alloimmunization in Women Identified at Higher Risk for Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

Brief Summary

      A prospective, non-interventional, natural history study to assess the occurrence of higher
      FNAIT risk across a broad population of different racial and ethnic characteristics and the
      occurrence of HPA-1a alloimmunization in these women.
    



Study Type

Observational


Primary Outcome

Number of participants with higher FNAIT risk characterized by race and ethnicity

Secondary Outcome

 Frequency of anti-HPA-1a maternal alloimmunization

Condition

Fetal and Neonatal Alloimmune Thrombocytopenia

Intervention

Clinical data collection

Study Arms / Comparison Groups

 Pregnant women
Description:  Women with higher risk of FNAIT

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

30000

Start Date

March 14, 2022

Completion Date

April 2024

Primary Completion Date

July 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Pregnant women (≥ 18 years of age) who have provided informed consent for the study.

        Exclusion Criteria:

          -  Participants with prior history of FNAIT
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, (203) 859-3820, [email protected]

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT05345561

Organization ID

IPA2002


Responsible Party

Sponsor

Study Sponsor

Rallybio IPA, LLC


Study Sponsor

, , 


Verification Date

April 2022